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A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT03293992
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a Phase I, multi-center, randomized, adaptive, investigator/patient-masked, placebo-controlled, parallel multiple-ascending dose study (Part A) with an extension including up to two selected doses from Part A and latanoprost 0.005% as active comparator (Part B).

Condition or disease Intervention/treatment Phase
Glaucoma, Open-angle Ocular Hypertension Drug: 0.01% RO7058584 Drug: 0.1% RO7058584 Drug: 1% RO7058584 Drug: Matching Placebo Drug: Latanoprost 0.005% Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-Center, Randomized, Adaptive, Investigator/Patient Masked, Multiple-Ascending Dose, Placebo and Active Comparator-Controlled Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7058584 Following 7 Days of Topical Instillation of Eye Drops in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: 0.01% RO7058584 or Matching Placebo Drug: 0.01% RO7058584
Once daily morning administration for 7 days

Drug: Matching Placebo
Once daily morning administration for 7 days

Experimental: 0.1% RO7058584 or Matching Placebo Drug: 0.1% RO7058584
Once daily morning administration for 7 days

Drug: Matching Placebo
Once daily morning administration for 7 days

Experimental: 1% RO7058584 or Matching Placebo Drug: 1% RO7058584
Once daily morning administration for 7 days

Drug: Matching Placebo
Once daily morning administration for 7 days

Experimental: RO7058584 and Latanoprost 0.005% Drug: 0.01% RO7058584
Once daily morning administration for 7 days

Drug: 0.1% RO7058584
Once daily morning administration for 7 days

Drug: 1% RO7058584
Once daily morning administration for 7 days

Drug: Latanoprost 0.005%
Once daily morning or evening dosing




Primary Outcome Measures :
  1. Incidence, Severity, and Causal Relationship of Ocular and Systemic Adverse Events (AEs) [ Time Frame: Up to 12 weeks ]
    An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  2. Incidence of Abnormal Laboratory Findings [ Time Frame: Up to 12 weeks ]
  3. Incidence of Blood Pressure Abnormalities [ Time Frame: Up to 12 weeks ]
  4. Incidence of Pulse Rate Abnormalities [ Time Frame: Up to 12 weeks ]
  5. Incidence of Electrocardiogram (ECG) Findings [ Time Frame: Up to 12 weeks ]
  6. Change From Baseline in Mean Intraocular pressure (IOP) After 7 Days of Study Drug Administration [ Time Frame: 7 days ]
    IOP will be assessed by Goldman Applanation tonometry.


Secondary Outcome Measures :
  1. Change From Baseline in Mean Intraocular pressure (IOP) at Matched Clock-Times After 7 Days of Study Drug Administration [ Time Frame: 7 days ]
    IOP will be assessed by Goldmann Applanation tonometry

  2. Cmax of RO7058584 [ Time Frame: Up to Day 8 ]
    Cmax is the maximum observed plasma concentration.

  3. Tmax of RO7058584 [ Time Frame: Up to Day 8 ]
    Tmax is the time to maximum observed plasma concentration.

  4. Ctrough of RO7058584 [ Time Frame: Up to Day 8 ]
    Ctrough is the concentration at the end of a dosing interval before the next dose administration.

  5. AUC0-24h of RO7058584 [ Time Frame: Up to Day 8 ]
    AUC0-24h is the area under the plasma concentration versus time curve (AUC) from Time 0 to 24 h post-dose.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 90 years of age inclusive, at the time of signing the informed consent form
  • Confirmed diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG) in both eyes as determined by the investigator at screening
  • Treatment-naïve participants or participants who are able to safely stop their Intraocular pressure (IOP)-lowering medication(s) prior to randomization according to the required minimum washout periods
  • At baseline visit, IOP ≥ 24 millimeters of mercury (mmHg) in the morning (8:00 AM ± 1h) and ≥ 22 mmHg in the afternoon (2:00 PM ± 1h) measurement in the same eye and ≤ 34 mmHg at all timepoints in both eyes
  • Best corrected logarithm of the minimum angle of resolution (logMAR) visual acuity score of 0.7 or better in each eye as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity test at screening
  • Central corneal thickness (pachymetry) measurement 450 to 620 micrometers (μm) in both eyes at screening
  • Cup-to-disc ratio ≤ 0.8 (both eyes) at screening
  • Anterior chamber angle is open and non-occludable (both eyes) as confirmed by the investigator by gonioscopy examination at screening

Exclusion Criteria:

  • Advanced visual field defects
  • Other forms of glaucoma than POAG or OHT
  • Any abnormality preventing reliable applanation tonometry
  • Any clinically significant corneal scarring, haze or opacity
  • Uncooperativeness of the participant that restricts adequate examination of IOP, ocular fundus or anterior chamber
  • Any presence or history of uveitis or other history of any ocular inflammatory disease.
  • History or signs of penetrating ocular trauma
  • Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease, according to the investigator's best judgment
  • History of any glaucoma surgery
  • History of refractive surgery
  • Any other intra-ocular surgery within six months of screening
  • Any active ocular disease requiring treatment.
  • Use of any listed prohibited medications
  • Current enrollment or past participation within the last 30 days before the screening visit in any other clinical study involving an investigational study treatment or any other type of medical research
  • Any participant who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293992


Locations
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United States, Arizona
Arizona Eye Center
Chandler, Arizona, United States, 85225
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
United Med Res Inst
Inglewood, California, United States, 90301
Eye research foundation
Newport Beach, California, United States, 92663
United States, Colorado
Rocky Mountain Lions Eye Inst
Aurora, Colorado, United States, 80045
United States, Georgia
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, United States, 30260
Coastal Research Associates
Roswell, Georgia, United States, 30076
United States, Texas
Texan Eye/Keystone Research
Austin, Texas, United States, 78731
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03293992     History of Changes
Other Study ID Numbers: BP39863
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Latanoprost
Pharmaceutical Solutions
Antihypertensive Agents